Identification of Hepatic Lesions

May 15, 2009 updated by: Bayer

A Prospective, Multicenter, Phase III b Clinical Study to Evaluate the Effectiveness of Unenhanced and SH U 555A (Resovist) Enhanced MRI, Compared to Contrast-Enhanced Dual-Phase Spiral CT in Assessing the Correct Final Therapy-Deciding Diagnosis, in Patients With Primary or Secondary Hepatic Malignancies.

Patients with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Chieti, Italy, 66100
      • L'Aquila, Italy, 67100
      • Roma, Italy, 00161
      • Roma, Italy, 00144
      • Udine, Italy, 33100
    • BA
      • Bari, BA, Italy, 70124
    • BO
      • Bologna, BO, Italy, 40100
    • BS
      • Brescia, BS, Italy, 25123
    • FI
      • Firenze, FI, Italy, 50100
    • GE
      • Genova, GE, Italy, 16132
    • MI
      • Milano, MI, Italy, 20132
      • Milano, MI, Italy, 20142
      • Milano, MI, Italy
    • PA
      • Palermo, PA, Italy
    • PI
      • Pisa, PI, Italy, 56126
    • SS
      • Sassari, SS, Italy, 07100
    • TO
      • Torino, TO, Italy, 10154
    • TS
      • Trieste, TS, Italy, 34149
    • VE
      • Verona, VE, Italy, 37134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Present with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment. There should not be more than five liver lesions on type visualized on CT.

    The patient should be in a condition that allows subsequent treatment.

  2. Be willing and able to continue study participation following administration of SH U 555 A to ensure completion of all procedures and observations required by the trial protocol.
  3. Sign and date fully informed consent prior to entry into the study.

Exclusion Criteria:

  • Patients under 18 years of age.
  • Patients weighing less than 35 kg.
  • Patients who have received any investigational drug within the 30 days prior to entering this study.
  • Patients who have previously entered this study or any other study performed with SH U 555 A.
  • Women who are pregnant or who are of childbearing potential and have not had a negative urine pregnancy test immediately prior to the administration of SH U 555 A. The urine pregnancy test should be performed in accordance with the manufacturer's recommendations.
  • Lactating women.
  • Patients who have any contraindication to MRI examination.
  • Patients who have received any contrast material in the 24 hours prior to SH U 555 A injection, or who are scheduled to receive any contrast material within 24 hours afterwards. (In the case of any liver specific agent (e.g. MnDPDP, SPIOs, Gd-BOPTA) this will be extended to 14 days prior to the study).
  • Patients who have received Lipiodol contrast material at any time in the past or are scheduled to receive this during the study period.
  • Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery).
  • Patients scheduled for liver biopsy within 24 hours, or who had a biopsy within the 24 hours prior to planned SH U 555 A injection.
  • Patients who are scheduled for, or are likely to require, surgery within 24 hours after SH U 555 A injection.
  • Patients with a history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
  • Patients with known hypersensitivity to any of the ingredients of SH U 555 A.
  • Patients with already clear op-indication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Procedure: Resovist (BAY86-4884, SH U 555 A)
Single bolus injection, followed by MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the proportion of correct final, therapy deciding diagnosis based on unenhanced plus SH U 555 A enhanced MR imaging compared to contrast-enhanced dual-phase spiral CT.

Secondary Outcome Measures

Outcome Measure
To assess the number, size , location and character of liver lesions.
To assess the diagnostic confidence of MRI and CT.
To assess the proportion of changed therapeutical decisions.
To assess sensitivity and specificity of MRI and CT.
To assess safety and tolerability of SH U 555 A administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion (ACTUAL)

May 1, 2003

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (ESTIMATE)

March 28, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2009

Last Update Submitted That Met QC Criteria

May 15, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90956
  • 304668

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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